Job Description
- Co-ordination and communication on routinely basis with US team.
- Updation of required status and database for Operations, Packaging, MST/ Technical Services .
- To work in collaboration with team members to create the highest quality documents and timely delivery of outputs consistently.
- Prepare and review PPQP, PPQR, PSP, PSR, CPVP, BBHS, regulatory modules (for submission/validation batches).
- Prepare and review Cleaning Validation documents (Matrix, CVP, CVSR & CVR's) in addition to timely monitoring of Annual Cleaning Verification Program, LOTC, DEHT & CEHT.
- Handling of CC, UD, PD, Event and Customer complaints as and when required.
- To prepare and review documents for manufacturing activities which includes but not limited to MPR, PBR, MPS, SOP and other manufacturing related documents.
- Prepares technical assessment reports and deviations investigations, etc.
Qualifications
B.Sc./ B.Pharm/ M.Sc./ M.Pharm
